Kornimate/medical-research-clean huggingface dataset:
phenylephrine infusion in cesarean delivery

Conditions: Cesarean Section Complications; Spinal Anesthesia

Summary: the investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75 mcg/kg/min) with fixed rate (0.75 mcg/kg/min which will stop of reactive hypertension occurred) and single shot (1.5 mcg/kg) phenylephrine

maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (cd). phenylephrine (pe) is the most popular vasopressor for prevention of post-spinal hypotension (psh) during cd; however, the most appropriate protocol for pe administration is still unknown. the most common pe protocols used for prophylaxis against psh are: single shot, fixed infusion, and variable infusion. a recent study reported that a dose of 1.5 mcg/kg is the most suitable single-shot dose for prophylaxis. another randomized controlled trial compared four doses of pe infusion and reported that 25 mcg/kg/min and 50 mcg/kg/min doses were the best doses for fixed infusion with accepted incidence of both psh as well as reactive hypertension. using variable infusion rate of pe had been recently introduced in another study with a starting dose of 0.75 mcg/kg/min. the variable rate infusion showed very good results regarding psh. in this study, the investigators will compare variable infusion of pe (at a starting rate of 0.75 mcg/kg/min) with fixed rate (0.75 mcg/kg/min which will stop if reactive hypertension occurred) and single shot protocol (1.5 mcg/kg)

Eligibility criteria:
inclusion criteria: * full term * pregnant women * scheduled for cesarean delivery exclusion criteria: * pre-eclampsia * eclampsia * hemorrhage * cardiac dysfunction * baseline low heart rate (below 60 bpm)
pharmacodynamic drug interaction between warfarin and amoxicillin-clavulanic acid

Conditions: Oral Anticoagulation; Deep Venous Thrombosis; Atrial Fibrillation; Pulmonary Embolism

Summary: several case reports indicate that the use of the antibiotic combination amoxicillin and clavulanic acid (am-clavac) can interact with warfarin pharmacodynamics. however, fever per se might also be responsible of these warfarin overdose reports, as well as the use of high dose paracetamol. the aim of the present study is to determine if am-clavac can increase the pharmacodynamics of warfarin among patients at steady state double blinded cross over controlled study vs placebo performed in 12 evaluable patients treated with warfarin with an inr target 2 to 3 and a stable inr and a stable dose.

double blinded cross over controlled study vs placebo performed in 12 evaluable patients treated with warfarin with an inr target 2 to 3 and a stable inr and a stable dose one period : seven consecutive days of amoxicillin(2g twice daily)- clavulanic acid (125 mg twice daily) association wash out period of at least 4 weak with the return to a stable inr and warfarin dose one period : seven consecutive days of placebo twice daily main outcome inr delta day7-day

Eligibility criteria:
inclusion criteria: * patients treated with warfarin (target inr 2 to 3) * stable anticoagulation (3 consecutive inr in the target) * stable dose * no infection * normal crp * age \>18 years * normal transaminase levels exclusion criteria: * drug allergy * penicillin allergy * alzheimer * cancer * thyroid disease * gastro intestinal chronic disease * frequent nausea or vomiting * cirrhosis * chronic renal failure (gfr\<60 ml/min) * frequent intake of paracetamol or nsaid * addict to drugs or alcool * st john's wort treatment or grapefruit juice intake * concomitant drugs (amiodarone, cimetidine, ssri, clofibrate, fenofibrate, diltiazem, fluconazole, itraconazole, isoniazide, voriconazole, métronidazole, miconazole , omeprazole, glucocorticoids, zileuton, ritonavir, rifampicin, carbamazepine, phenytoin, phenobarbital) * antibiotic use during the 3 last weeks * pregnancy

Keywords: warfarin drug interaction pharmacogenetics amoxicillin clavulanic acid
application of nanotechnology and chemical sensors for diagnosis of decompensated heart failure by respiratory samples

Conditions: Heart Failure

Summary: application of nanotechnology and chemical sensors for diagnosis of decompensated heart failure by respiratory samples. breath testing, which links specific volatile molecular biomarkers in exhaled breath to medical conditions, is becoming increasingly popular as a non-invasive and potentially inexpensive diagnostic method for various diseases. na-nose performs odor detection from exhaled breath, thus producing a distinct fingerprint for each mixture of analytes. several studies have been published, stating the advantages of these sensors, leading to promising outcomes in several fields. the na-nose breath test would be fast (examination and results would be obtained within 5-10 min), inexpensive, eventually portable (smaller than desktop computer), non-invasive and free of any side effects.


Eligibility criteria:
inclusion criteria: * signed informed consent * ≥ 18 years of age, male or female * left ventricular ejection fraction less than 40% or known to suffer from heart failure with preserved ejection fraction * in decompensated heart failure group: dyspnea with confirmation of pulmonary congestion/edema by chest x-ray exclusion criteria: * pericardial diseases, e.g. constrictive pericarditis, tamponade * significant congenital heart disease, up to the investigator's opinion * life-threatening or uncontrolled arrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate \>110 beats per minute. * acute st elevation myocardial infarction * pregnant women * patients with pulmonary embolism * probable alternative diagnoses that in the opinion of the investigator could account for patient's hf symptoms (i.e., dyspnea), such as: 1. significant pulmonary disease 2. anemia with hemoglobin \<10 g/dl * participation in another study
urinary markers of detrusor overactivity in spina bifida patients

Conditions: Spina Bifida; Multiple Sclerosis; Spinal Cord Injury; Overactive Bladder

Summary: the purpose of this study is to assess diagnostic performance of urinary markers of detrusor overactivity (nerve growth factor (ngf), brain-derived neurotrophic factor (bdnf), adenosine triphosphate (atp), prostaglandine e2) in detected high pressure bladder un spina bifida patients.


Eligibility criteria:
inclusion criteria: study arm: * spina bifida patient * seen consecutively in outpatient clinics * age \> 18 years-old control arm: * patients with multiple sclerosis or spinal cord injury or overactive bladder * seen consecutively in urodynamics * with lower urinary tract symptoms * age \> 18 years-old exclusion criteria: * positive urine culture * history of urologic neoplasms * history of interstitial cystitis
alginate-based reflux suppressant and magnesium-aluminium antacid gel for treatment of heartburn in pregnancy

Conditions: Heartburn in Pregnancy

Summary: this study evaluates the efficacy of alginate-based reflux suppressant and magnesium-aluminium antacid gel for treatment of heartburn in pregnancy. half of the participants will receive alginate-based reflux suppressant, while the other half will receive magnesium-aluminium antacid gel.


Eligibility criteria:
inclusion criteria: * pregnant women gestational age less than 36 weeks with heartburn exclusion criteria: * having medical disease that contraindicated to use study drug * allergic to alginate-based reflux suppressant and magnesium-aluminium antacid gel
cerebrospinal fluid levels of erlotinib in patients receiving erlotinib for stage iii non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: determining whether erlotinib passes into the cerebrospinal fluid may help in planning treatment for some types of cancer. purpose: this clinical trial is studying how well erlotinib is able to pass into the cerebrospinal fluid of patients receiving erlotinib for stage iii non-small cell lung cancer.

objectives: * determine the cerebrospinal fluid penetration of erlotinib in a subset of patients who are undergoing treatment with erlotinib for stage iii non-small cell lung cancer and have no cns metastatic disease. outline: this is a pilot, nonrandomized study. patients will undergo single lumbar puncture (lp) to remove cerebrospinal fluid for analysis. after completion of study, patients will be monitored for 1 month after lp to assess for any lp-related complications. projected accrual: a total of 10 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * patients must be enrolled in the trial: "a phase i/ii trial of neoadjuvant paclitaxel, carboplatin and osi-774 (tarceva) with concurrent accelerated hyperfractionation radiation followed by maintenance therapy with osi-774 for stage iii non-small cell lung cancer," principal investigator: t. mekhail, m.d. * patient must be in maintenance therapy phase of the study and have received erlotinib for ≥ 1 week * no known cns primary or metastatic cancer at any time prior to time of enrollment * no mri evidence of pathological enhancement at the time of study entry patient characteristics: * patients must use adequate birth control measures while in the study * no significant side effects to erlotinib that require dose reduction or interruption * none of the following medical issues which could make a lumbar puncture unsafe: * platelets \< 100,000/mm³ * inr \> 1.1 * known bleeding dyscrasia * absolute neutrophil count \< 1,500/mm³ * ongoing systemic bacterial infection prior concurrent therapy: * patients on modest or anti-epileptic therapy must be on nonenzyme-inducing drug only, including any of the following: * neurontin * lamictal * depakote, depakene * felbatol * keppra * gabitril * topimax * zonegran * no concurrent enzyme-inducing anti-epileptic drugs such as phenytoin, carbamazepine, or phenobarbital * no concurrent other drug known to affect the metabolism of erlotinib * no concurrent anticoagulant therapy

Keywords: stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer
testing a community intervention to increase aspirin use

Conditions: Myocardial Infarction; Stroke

Summary: this research will test the effect of mass media or mass media plus a clinic based education program will improve appropriate aspirin use for cardiovascular disease prevention. it is a group randomized design of 24 geographic areas in minnesota with adjacent states serving as controls.

proposed is a demonstration and implementation project to increase the appropriate use of aspirin for primary prevention of acute myocardial infarction and stroke in the population of minnesota. although significant progress in the reduction of acute myocardial infarction and stroke is apparent, these cardiovascular disorders continue as the leading causes of morbidity and mortality. in recent years, and in the context of the positive results from large randomized clinical trials, there is growing consensus that aspirin, when appropriately used, reduces cardiovascular morbidity in men aged 45-79 and women aged 55-79 years. the use of aspirin for primary prevention was recommended in the u.s. preventive services task force report in 2009 and more recently in the cdc/cms 'million hearts' abcs (aspirin, blood pressure, cholesterol, smoking) campaign. aspirin use is also recommended in the healthy people 2020 goals. however, many adults who would benefit, are not taking aspirin. the investigators have been fortunate to receive a large philanthropic donation to launch a campaign to increase appropriate aspirin use in the state of minnesota. the proposed grant requests funding to evaluate that campaign and the innovative approaches it proposes. in the context of a innovative mass media effort, the investigators intend to test new methods for health system change to increase appropriate aspirin use. using a two-arm design, the investigators have defined 24 geographic areas in the state that will form the basis for a group-randomized trial. this design will allow us to distinguish the effects of the intervention methods. the interventions will be evaluated by sequential surveys of the target-age general population at baseline and follow-up. appropriate aspirin use in that population will be the primary goal and endpoint. simultaneous surveys of adjacent upper midwestern states (iowa, north and south dakota, wisconsin) will assess secular trends. morbidity and mortality data will monitor disease trends and complications associated with aspirin use. a substantial pilot study in a middle sized community in northern minnesota allows us to refine and validate our intervention and measurement methods at the community level. this pilot also demonstrated behavior change of a magnitude supportive of our design assumptions. this program, if successful, should result in a generalizable program tested in a real world population setting.

Eligibility criteria:
inclusion criteria: * healthy men age 45-79. * healthy women age 55-79 * per uspstf 2009 recommendations exclusion criteria: * history of cardiovascular disease * aspirin allergy * serious life-limiting illness

Keywords: cardiovascular disease
postpartum pelvic assisted recovery with leva

Conditions: Postpartum Pelvic Floor Function and Symptoms

Summary: the goal of this prospective cohort study is to evaluate the feasibility of postpartum pelvic floor muscle training using an fda-cleared digital therapeutic motion-based device. in addition to assessing feasibility, investigators also will evaluate bladder and bowel function, pelvic organ prolapse symptoms, and vaginal and perineal pain in the immediate postpartum period and at 3 and 6 months postpartum. investigators also will assess sexual function at 3 and 6 months postpartum. participants will use the motion-based device for postpartum pelvic floor muscle training and will complete electronically administered surveys at 3 and 6 months postpartum.


Eligibility criteria:
inclusion criteria: * spontaneous vaginal delivery within the last 4-8 weeks * age ≥ 18 years * ambulatory * willing and able to consent to participate. * english speaking * owns a smartphone exclusion criteria: * operative or cesarean delivery * obstetric delivery at less than 20 weeks gestation * third- or fourth-degree perineal laceration * episiotomy * multiples

Keywords: postpartum pelvic muscle training postpartum pelvic floor postpartum pelvic floor physical therapy postpartum urinary incontinence postpartum bowel incontinence postpartum pelvic floor recovery
a study to evaluate the safety and efficacy of ptc518 in participants with huntington's disease (hd)

Conditions: Huntington Disease

Summary: the primary goal of this study is to evaluate the safety and pharmacodynamic effects of ptc518 compared with placebo in participants with hd.

participants will first be randomized to part a or part b or parts d or e in a 1:1 randomization ratio, depending on their huntington's disease integrated staging system (hd-iss) staging criteria and then to active treatment (ptc518 5 mg in parts a and d and 10 mg in parts b and e) or matching placebo within each part in a 2:1 ratio of active treatment to placebo. a drug safety monitoring board (dsmb) charter will undertake an unblinded review of safety data from the 5 and 10 mg dosing groups and provide a recommendation on when parts c and f (with a 20 mg active treatment arm) can be initiated. at that time, participants will be randomized to any study part that is currently open for enrollment, and then to either active treatment or placebo (in a 2:1 ratio) within that part.

Eligibility criteria:
key inclusion criteria: * genetically confirmed hd diagnosis with a cytosine-adenine-guanine (cag) repeat length from 40 to 50, inclusive eligibility for hd-iss stage 2 group (parts a, b, and c): * a unified huntington's disease rating scale (uhdrs)-independence scale (is) score of 100 * a uhdrs total functional capacity (tfc) score of 13 * a score between 0.18 and 4.93 inclusive on the normed version of the hd prognostic index (pinhd) eligibility for hd-iss mild stage 3 group (parts d, e, and f): * a uhdrs total functional capacity (tfc) score of 11 or 12, or a uhdrs tfc score of 13 with an uhdrs is score of \<100 key exclusion criteria: * receipt of an experimental agent within 90 days or 5 half-lives prior to screening or anytime over the duration of this study, ribonucleic acid (rna)- or deoxyribonucleic acid (dna)-targeted hd-specific investigational agents such as antisense oligonucleotides, cell transplantation, or any other experimental brain surgery * any history of gene therapy exposure for the treatment of hd * participation in an investigational study or investigational paradigm (such as exercise/physical activity, cognitive therapy, brain stimulation, etc) within 90 days prior to screening or anytime over the duration of this study * any medical history of brain or spinal disease that would interfere with the lumbar puncture process safety assessments * any medical history or condition that would interfere with the ability to complete the protocol-specified assessments (for example, implanted shunt, conditions precluding magnetic resonance imaging \[mri\] scans) * pregnancy, planning on becoming pregnant during the course of the study or within 6 months of end of treatment, or currently breastfeeding note: other inclusion and exclusion criteria may apply.

Keywords: neurodegenerative disorder rare disease
exploratory study on the timing of multiple sclerosis (ms) symptoms

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: the investigators' overall hypothesis is that appearance or worsening of relapsing-remitting multiple sclerosis (rr-ms) symptoms are affected by various factors including stress, hormonal cycles, illness and missed medications.

fluctuations in ms symptoms in women with rr-ms might be affected by a variety of factors. to determine which factors are important, we are asking subjects to fill out a diary and calendar on a daily basis for 90 days. after an initial instructional meeting over the phone, the materials are filled out at home and returned monthly via postage-paid envelopes provided by the study. compensation ($10 gift card) is sent after each monthly diary is received. the diary includes a list of symptoms and a rank scale for the women to show subtle changes in ms symptoms. the calendar allows the subject to denote additional factors such as stress, hormonal cycles, illnesses or immunizations and changed or missed medications. we anticipate that statistical analysis will reveal which of these factors affect women with relapsing-remitting multiple sclerosis.

Eligibility criteria:
inclusion criteria: * females * diagnosed with relapsing-remitting multiple sclerosis exclusion criteria: * male * no diagnosis of relapsing-remitting ms * diagnosis of any other autoimmune disease or fibromyalgia * peri-, post-, or surgically menopausal * pregnant within past year or nursing * history of chemotherapy * on experimental medications * treatment with steroids in the last 30 days

Keywords: multiple sclerosis ms relapsing-remitting multiple sclerosis rr-ms women
epoprostenol for injection in pulmonary arterial hypertension - extension of ac-066a401

Conditions: Pulmonary Arterial Hypertension

Summary: this is an open-label, non-randomized extension to study ac-066a401. the study will assess safety and tolerability of act-385781a and flolan (epoprostenol sodium) while providing a means for continuing treatment after ending participation in study ac-0066a401.


Eligibility criteria:
inclusion criteria: 1. signed informed consent prior to initiation of any study-mandated procedure 2. patients who completed participation in study ac-066a401 3. patients who have not obtained authorization for commercial act-385781 and flolan at the time of ending participation in study ac-066a401 exclusion criteria: 1. patients who prematurely discontinued study drug in study ac-066a401 2. patients for whom continued treatment with either act-385781 and flolan is no longer considered appropriate 3. known hypersensitivity to the investigational drug or comparative drug or drugs of the same class, or any of their excipients 4. any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease 5. known concomitant life-threatening disease with a life expectancy \< 12 months

Keywords: pulmonary arterial hypertension pah epitome-1
primary dependence to analgesic drugs

Conditions: Addiction

Summary: abuse of analgesics represents an important part of prescription drug abuse. the consequences in terms of morbidity and mortality at the population level could reach worryingly high levels, as illustrated by the us context. this issue should not focus only on opioid analgesics, but must also account for some antiepileptics or antidepressants with abuse potential (for example, pregabalin or gabapentin). in france, reports related to tramadol abuse are increasing, in particular since dextropropoxyphene withdrawal. trends of growing abuse are also reported for other analgesics. patients with no history of primary dependence constituted a significant proportion of those developing a tramadol abuse. there is therefore a need for early identification of these patients and to raise awareness of health professionals on this issue, in particular in primary care. given the extensive use of analgesic drugs in france, the problem of primary dependence should not be neglected. since it will affect people who have no history of drug abuse, strategies for identification and prevention are differing from a population already using psychotropic products for example.

to date, prescription drug abuse has been considered in terms of the secondary or tertiary prevention, and primary prevention remains poorly explored. by reconstructing the entire trajectories of patients having developed primary drug dependence, from the genesis of first drug exposures, investigators will identify patients' profiles and early changes in drug use that could accurately predict future complications. pharmacoepidemiological methods are particularly relevant in the field of abuse and drug dependence. by definition, specialized care seeking can only be achieved after emergence and identification of the problem. outpatients data obtained through medico-administrative database are then the only source of evidence that could enable to ascertain accurately history of past drug consumption

Eligibility criteria:
inclusion criteria: * subjects included in the sniiram (french national inter-scheme health insurance information system) database * age \>18 at index date (date of first analgesic dispensing) * at least three dispensing of analgesic drugs * at least two years of available follow-up at the date of first analgesic dispensing in the sniiram database * no dispensing for any of the analgesics of interest in the past 12 months (selection of new users only) exclusion criteria: * none

Keywords: pharmacology psychiatry